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Cybrexa Therapeutics Expands Scientific Advisory Board With Appointment of Leader…
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Cybrexa Therapeutics Expands Scientific Advisory Board With Appointment of Leader in Lung Cancer Research Roy Herbst, M.D., Ph.D.
Expansion of SAB in advance of IND submission for CBX-12 and start of Phase I/II study in solid tumors
New Haven, Conn., August 3, 2020 – Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ tumor targeting platform, today announced that it has expanded its Scientific Advisory Board with the appointment of Roy S. Herbst, M.D., Ph.D., Ensign Professor of Medicine, Professor of Pharmacology, Chief of Medical Oncology, Director of the Yale SPORE in Lung Cancer, and Associate Director for Translational Research at Yale Cancer Center (YCC) and Yale School of Medicine.
Dr. Herbst has worked over several decades as a pioneer of personalized medicine and immunotherapy to identify biomarkers and bring novel targeted treatments and immunotherapies to patients, serving as principal investigator for numerous clinical trials testing these agents in advanced stage lung cancers. This work led to the approval of several therapies (such as gefitinib, cetuximab, bevacizumab, axitinib, atezolizumab, and pembrolizumab), which have revolutionized the field and greatly enhanced patient survival. His work on “umbrella” trials has galvanized the field of targeted therapy and cancer drug approvals at the FDA. Nationally, he is at the forefront of personalized medicine and works closely with public-private partnerships to develop large clinical studies, such as Lung-MAP. The NCI Lung SPORE he leads has identified new mechanisms of sensitivity and resistance to immunotherapy.
Dr. Herbst has authored or co-authored more than 300 publications, including peer-reviewed journal articles, abstracts, and book chapters. His work has appeared in many prominent journals, such as the Journal of Clinical Oncology, Clinical Cancer Research, Lancet, and the New England Journal of Medicine. Work published in Nature was awarded the 2015 Herbert Pardes Clinical Research Excellence Award by the Clinical Research Forum.
Dr. Herbst was a member of the National Cancer Policy Forum, for which he organized an IOM meeting focused on policy issues in personalized medicine. He is a member of the Board of Directors of the American Association of Cancer Research, where he chairs the Tobacco Task Force, as well as the American Society of Clinical Oncology. Additionally, he is a member of the Board of Directors of the International Association for the Study of Lung Cancer (IASLC). He is a fellow of the American College of Physicians and an elected member of the Association of American Physicians. He is vice chair for developmental therapeutics for Southwestern Oncology Group’s (SWOG) Lung Committee and the Principal Investigator of the Lung-MAP master protocol. In 2015, his team at Yale was awarded a Lung Cancer SPORE by the NCI (renewed in 2020), and he serves as a principal investigator for an AACR/ Stand Up to Cancer Dream Team grant.
Dr. Herbst said, “I am excited to join Cybrexa’s scientific advisory board as CBX-12 approaches the clinic. I believe that the alphalexTM platform and programs have tremendous potential, particularly in solid tumor patients who are refractory to immunotherapy and in combination with immunotherapy drugs. I look forward to providing Cybrexa with guidance as they make the transition to become a clinical stage company over the next year.”
Per Hellsund, President and CEO of Cybrexa, added, “We are honored to have Dr. Herbst join our scientific advisory board. His contributions will be invaluable as we expand our clinical strategy in solid tumors.”
About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care. pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces. pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc. alphalex™ represents the disruptive next generation in tumor targeting. View a video of the mechanism of action of the technology at www.cybrexa.com.
About Cybrexa
Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs. Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.
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Investor Relations
Westwicke, an ICR Company
Stephanie Carrington
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Cybrexa Therapeutics Completes Successful Pre-IND Meeting With FDA for CBX-12…
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Cybrexa Therapeutics Completes Successful Pre-IND Meeting With FDA for CBX-12 (alphalexTM-exatecan), a Novel Treatment for Solid Tumors
Positive pre-IND Meeting with FDA supports plan to file IND in fourth quarter 2020
New Haven, Conn., July 7, 2020 – Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ tumor targeting platform, today announced that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its proposed IND and Phase I/II study for its lead candidate, CBX-12 (alphalexTM-exatecan).
Cybrexa plans to submit the IND application for CBX-12 during the fourth quarter of 2020 and to initiate a Phase I/II clinical trial evaluating CBX-12 in advanced solid tumors in the first half of 2021. The Phase I portion of the study will establish the safety profile and a recommended Phase II dose (RP2D). This initial clinical trial will also evaluate efficacy across a number of solid tumors and establish proof of mechanism for the alphalexTM platform.
CBX-12 includes a highly potent topoisomerase I inhibitor payload that is in the same class as the payloads used by antibody-drug conjugates (ADCs) ENHERTU® and TRODELVY™. In contrast to these ADCs, CBX-12 is able to target cancer cells independent of antigen overexpression. alphalexTM conjugates have efficacy in the substantial patient populations that cannot be effectively treated with ADCs, as ADCs can be used only in patients that overexpress antigens.
CBX-12 was selected based on its strong efficacy and solid safety profile in preclinical models. Preclinical efficacy and safety data for CBX-12 was recently presented in a poster at the American Association for Cancer Research (AACR) Virtual Annual Meeting II.
Per Hellsund, President and CEO of Cybrexa, said, “CBX-12 will be the first therapeutic generated from the alphalex™ platform to move into the clinic. Not only is this validating for our pipeline, but it also represents the first time a tumor selective drug that is antigen-independent, delivers payload intracellularly, and is capable of penetrating large tumor masses as well as treating small metastases, will enter into human studies.”
Vishwas Paralkar, PhD, Cybrexa Chief Scientific Officer, added “We are excited to prepare our IND filing and first-in-human study. We anticipate that CBX-12 will demonstrate efficacy in several solid tumors and believe there is potential for the drug in combination with immuno-oncology therapies as well.”
About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care. pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces. pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc. alphalex™ represents the disruptive next generation in tumor targeting. View a video of the mechanism of action of the technology at www.cybrexa.com.
About Cybrexa
Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs. Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.
Media Contact
Investor Relations
Westwicke, an ICR Company
Stephanie Carrington
646-277-1282
Cybrexa Therapeutics to Present First Efficacy and Safety Data From its Lead Program CBX-12 and Initial Data From CBX-13 at the American Association for Cancer Research (AACR) Virtual Annual Meeting II
New Haven, Conn., May 15, 2020 – Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ tumor targeting platform, today announced that two posters featuring Cybrexa’s pipeline will be presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting II, which will be held June 22-24, 2020.
The following abstracts are now available on the AACR website at www.aacr.org.
- Title: CBX-12: A low pH targeting alphalex™-exatecan conjugate for the treatment of solid tumors
- Session Type: Poster Session
- Session Title: Emerging Drug Delivery Systems
- Abstract Number: 3222
- Title: CBX-13: Development of alphalex™-toxin low pH targeting conjugates for the treatment of solid tumors
- Session Type: Poster Session
- Session Title: Emerging Drug Delivery Systems
- Abstract Number: 3287
CBX-12, Cybrexa’s lead candidate, is a conjugate that includes the highly potent and toxic topoisomerase I inhibitor, exatecan. CBX-12 demonstrated remarkable efficacy across HER2-negative solid tumors in preclinical models. CBX-12 displays enhanced stability in plasma in vivo, undergoing only 0.002% warhead release over 30 hours in circulation and demonstrating exquisite selectivity for tumor over normal tissues in mouse tumor models. “The tumor selectivity of this conjugate is critical to the long-lasting efficacy and safety profile CBX-12 demonstrated across preclinical models,” said Vishwas Paralkar, PhD, Chief Scientific Officer of Cybrexa. “CBX-12 shows tremendous potential across a number of solid tumors and avoids the bone marrow and gastrointestinal toxicities associated with the warhead.”
Cybrexa is also working on the CBX-13 program, a conjugate that includes the highly potent maytansine DM4. The poster presents data for potential CBX-13 candidates in HER2-negative xenograft models that are un-targetable by competing therapies. The candidates demonstrate single digit nanomolar potency in vitro.
Per Hellsund, President and CEO of Cybrexa, commented, “The preclinical results for CBX-12 and CBX-13 were striking and led us to accelerate the development of both programs. CBX-12 is on-track to enter IND-enabling studies shortly, and we look forward to testing the drug in a Phase I/II study in advanced solid tumors next year.”
About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care. pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces. pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc. alphalex™ represents the disruptive next generation in tumor targeting. View a video of the mechanism of action of the technology at www.cybrexa.com.
About Cybrexa
Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs. Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.
Media Contact
Investor Relations
Westwicke, an ICR Company
Stephanie Carrington
646-277-1282